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A Phase I/II Clinical Trial of the Hypomethylating Agent Azacitidine (Vidaza) With the Nanoparticle Albumin Bound Paclitaxel (Abraxane) in the Treatment of Patients With Advanced or Metastatic Solid Tumors and Breast Cancer


Phase 1/Phase 2
18 Years
N/A
Open (Enrolling)
Both
Advanced or Metastatic Solid Tumors, Advanced or Metastatic Breast Cancer

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Trial Information

A Phase I/II Clinical Trial of the Hypomethylating Agent Azacitidine (Vidaza) With the Nanoparticle Albumin Bound Paclitaxel (Abraxane) in the Treatment of Patients With Advanced or Metastatic Solid Tumors and Breast Cancer


The phase I part of the study will enroll patients with advanced or metastatic solid tumors
who have failed at least one previous treatment. The purpose of the phase I part is to
assess the safety of the investigational treatment and select the recommended phase II
dose-regimen. The phase II part of the study will enroll patients with advanced or
metastatic HER2-negative breast cancer who have not received treatment for their metastatic
disease. The purpose of the phase II part of the study is to assess safety and efficacy of
the investigational treatment in breast cancer. The study doctor will determine what phase
patients will be enrolled in.


Inclusion Criteria:



1. For phase I, any solid tumors, including lymphoma, that progressed or were stable as
best response on at least one previous therapy and are evaluable.

2. For phase II, pathologically confirmed breast cancer, measurable disease, no prior
treatments for recurrent or metastatic breast cancer.

3. Her-2/neu negative (Phase II)

4. Negative pregnancy test for female subjects

5. Women of childbearing potential should be advised to avoid becoming pregnant and men
should be advised to not father a child while receiving treatment with azacitidine or
nab-paclitaxel. investigator.

6. Male or female for phase I and female for phase II, >19 years of age and any race.

Exclusion Criteria:

1. Major surgery, radiotherapy, chemotherapy or investigational agents within 4 weeks of
treatment day 1

2. Known brain or leptomeningeal metastases

3. Prior taxanes (except for adjuvant therapy more than 6 months prior to treatment day
1) (phase II)

4. Active infection requiring antibiotic therapy

5. History of allergy or hypersensitivity to nab-paclitaxel, albumin or a taxane

6. Grade 2 or greater motor or sensory neuropathy

7. Prior cytotoxic chemotherapy for recurrent or metastatic breast cancer (phase II
portion)

8. Uncontrolled hypertension, arrhythmia, congestive heart failure or angina. Patients
who have had a myocardial infarction or cardiac surgery should be at least 6 months
from the event and free of active symptoms.

9. Known or suspected hypersensitivity to azacitidine or mannitol

10. Pregnant or breast feeding

11. Patients with advanced malignant hepatic tumors

12. Malignancy other than breast carcinoma (phase II)

13. Known HIV infection or chronic hepatitis B or C

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Phase I: To assess safety of Vidaza and Abraxane combination and to select the recommended phase II dose-regimen

Outcome Time Frame:

6 months

Safety Issue:

Yes

Principal Investigator

Hung T Khong, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Utah

Authority:

United States: Institutional Review Board

Study ID:

HCI53993

NCT ID:

NCT00748553

Start Date:

September 2008

Completion Date:

November 2013

Related Keywords:

  • Advanced or Metastatic Solid Tumors
  • Advanced or Metastatic Breast Cancer
  • Breast Neoplasms
  • Neoplasms

Name

Location

University of Utah Huntsman Cancer InstituteSalt Lake City, Utah  84112